Combined Therapies for Recurrent Brain Cancer
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Monteris Medical
No Placebo Group
Approved in 6 jurisdictions
Trial Summary
What is the purpose of this trial?Randomized, post-market multi-center study investigating the efficacy of two sets of treatment algorithms in brain metastases (BM) patients at the time of first intervention for radiographic progression after stereotactic radiosurgery (SRS), with or without surgery.
Is Radiation Therapy a promising treatment for recurrent brain cancer?Radiation Therapy is a promising treatment for recurrent brain cancer because it can precisely target tumors while minimizing damage to healthy brain tissue. Advanced techniques like stereotactic radiotherapy and radiosurgery have shown effectiveness in controlling tumor growth and improving survival rates in patients with recurrent brain tumors. These methods offer a feasible option for managing brain cancer that has returned, providing hope for better outcomes.5791113
What safety data is available for combined therapies in recurrent brain cancer treatment?The safety data for combined therapies in recurrent brain cancer treatment can be inferred from various studies on related therapies. The ASTRO Safety White Paper Update highlights the importance of quality and patient safety in image-guided radiation therapy (IGRT), which is now widely used in clinical practice. A study on salvage re-irradiation with stereotactic radiotherapy (SRT) for recurrent glioma using CyberKnife evaluates toxicity and efficacy, indicating ongoing research into safety. Another study on advanced radiotherapy techniques, including intensity-modulated radiotherapy (IMRT) and IGRT, reports late grade 2 or higher gastrointestinal and genitourinary toxicities, emphasizing the need for careful consideration of these techniques. Additionally, a phase II trial protocol investigates the tolerability of regional hyperthermia with dose-escalated radiotherapy, and a systematic review on reirradiation using external beam or stereotactic radiation therapy discusses toxicity outcomes. These studies collectively provide insights into the safety considerations of these therapies.6781012
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have used bevacizumab within 4 weeks of starting the study.
What data supports the idea that Combined Therapies for Recurrent Brain Cancer is an effective treatment?The available research shows that combined therapies, such as radiotherapy and stereotactic radiosurgery, are effective for treating recurrent brain cancer. For example, reirradiation, which involves giving radiation treatment again, has been shown to improve survival and reduce symptoms with minimal side effects. Additionally, salvage stereotactic radiosurgery, a precise form of radiation, has demonstrated good results in controlling brain tumors and extending patient survival. These treatments are considered relatively safe and effective compared to other options, making them a promising choice for managing recurrent brain cancer.12347
Eligibility Criteria
This trial is for adults over 18 who've had brain metastases treated with SRS at least 3 months ago. They must be stable on low-dose steroids, able to undergo biopsy and laser therapy, and commit to the study's follow-up. Women of childbearing age need a negative pregnancy test and agree to use contraception.Inclusion Criteria
I am 18 years old or older.
My cancer can be biopsied and treated with laser therapy.
I've been stable for 3 days on a low steroid dose.
I am mostly able to take care of myself.
My brain tumor is growing despite previous treatments.
I am a woman and my pregnancy test was negative.
I have brain metastases from a cancer that did not originate in the brain.
Exclusion Criteria
My cancer outside the brain is quickly getting worse.
I do not have any serious infections or other major health issues.
I cannot have surgery due to my health condition.
I have cancer that has spread to the lining of my brain and spinal cord.
I cannot undergo or am not eligible for stereotactic radiosurgery.
I am receiving treatment for another cancer besides the one being studied.
I have more than 3 tumors that are getting worse.
I have recently been diagnosed with brain metastases.
I cannot take steroids due to health reasons.
Treatment Details
The REMASTer trial compares two treatment strategies after initial SRS for brain metastases: Radiation Therapy versus Laser Interstitial Thermal Therapy combined with Steroid Therapy. It's randomized, meaning patients are put into groups by chance.
2Treatment groups
Experimental Treatment
Group I: Recurrent TumorExperimental Treatment2 Interventions
Receives Laser Interstitial Thermal Therapy (LITT) followed by surveillance or Receives Laser Interstitial Thermal Therapy (LITT) followed by hypofractionated radiation therapy (RT).
Group II: Radiation NecrosisExperimental Treatment2 Interventions
Receives Laser Interstitial Thermal Therapy (LITT) and best medical management with steroids or Receives best medical management with steroids.
Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇺🇸 Approved in United States as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇦 Approved in Canada as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇯🇵 Approved in Japan as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇳 Approved in China as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇭 Approved in Switzerland as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
Find a clinic near you
Research locations nearbySelect from list below to view details:
Kettering HealthKettering, OH
Cleveland ClinicCleveland, OH
UCLALos Angeles, CA
Medical College of WisconsinMilwaukee, WI
More Trial Locations
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Who is running the clinical trial?
Monteris MedicalLead Sponsor
References
Improving radiotherapy for brain tumors. [2005]Radiation oncologists treating patients with primary brain tumors are faced with two important issues: How to improve the cure rate over that which is achievable with the current radiotherapy modalities and how to decrease long-term morbidity while maintaining or improving the cure rate. Several new approaches are being studied, including interstitial implants, stereotactic radiosurgery, new radiation modalities, radiosensitizers, hyperthermia, and altered fractionation programs. It is nonetheless important to remember that such innovative radiotherapy must be incorporated into the overall multimodal therapy for patients with primary malignant brain tumors.
Radiotherapy and chemotherapy of brain metastases. [2018]The authors have reviewed the results, the indications and the controversies regarding radiotherapy and chemotherapy of patients with newly diagnosed and recurrent brain metastases. Whole-brain radiotherapy, radiosurgery, hypofractionated stereotactic radiotherapy, brachytherapy and chemotherapy are the available options. New radiosensitizers and cytotoxic or cytostatic agents are being investigated. Adjuvant whole brain radiotherapy, either after surgery or radiosurgery, and prophylactic cranial irradiation in small-cell lung cancer are discussed, taking into account local control, survival, and risk of late neurotoxicity. Increasingly, the different treatments are tailored to the different prognostic subgroups, as defined by Radiation Therapy Oncology Group RPA Classes.
Reirradiation for progressive brain metastases. [2022]Brain metastases constitute one of the most common distant metastases of cancer and are increasingly being detected with better diagnostic tools. The standard of care for solitary brain metastases with the primary disease under control is surgery followed by radiotherapy. Radiotherapy is also the primary modality for the treatment of multiple brain metastases, and improves both the quality of life and survival of patient. Unfortunately, more than half of these treated patients eventually progress leading to a therapeutic dilemma. Another course of radiotherapy is a viable but underutilized option. Reirradiation resolves distressing symptoms and has shown to improve survival with minimal late neurotoxicity. Reirradiation has conventionally been done with whole brain radiotherapy, but now studies with stereotactic radiosurgery have also shown promising results. In this review, we focus on reirradiation as a treatment modality in such patients. We performed a literature search in MEDLINE (www.pubmed.org) with key words brain metastases, reirradiation, whole brain radiotherapy, stereotactic radiosurgery, interstial brachytherapy, and brain. The search was limited to the English literature and human subjects.
Salvage stereotactic radiosurgery for brain metastases. [2013]Recurrent or progressive brain metastases after initial treatment represent a common clinical entity mainly due to increased survival of cancer patients. From the various available treatment modalities, salvage stereotactic radiosurgery seems to be the most commonly used. Many clinical studies of class of evidence III have demonstrated satisfied results concerning the local brain control and survival of patients with relapsing brain disease. Also stereotactic radiosurgery is considered a relatively safe modality with low incidence of brain toxicity side effects. It is obvious that well-designed, randomized, prospective studies are necessary for the evaluation of the stereotactic radiosurgery as salvage treatment and for the establishment of guidelines for the selection of patients most suitable for this treatment option. The increasing number of patients with relapsing brain metastatic disease will act as a pressure to this direction.
Efficacy of stereotactic radiotherapy as salvage treatment for recurrent malignant gliomas. [2018]To evaluate the efficacy and toxicity of CyberKnife stereotactic radiotherapy (SRT) for recurrent glial tumors previously treated with high-dose radiotherapy.
Regional hyperthermia and moderately dose-escalated salvage radiotherapy for recurrent prostate cancer. Protocol of a phase II trial. [2021]Current studies on salvage radiotherapy (sRT) investigate timing, dose-escalation and anti-hormonal treatment (ADT) for recurrent prostate cancer. These approaches could either be limited by radiation-related susceptibility of the anastomosis or by suspected side-effects of long-term ADT. A phase II protocol was developed to investigate the benefit and tolerability of regional hyperthermia with moderately dose-escalated radiotherapy.
Feasibility of Salvage Re-irradiation With Stereotactic Radiotherapy for Recurrent Glioma Using CyberKnife. [2019]To evaluate the toxicity and efficacy of re-irradiation with salvage stereotactic radiotherapy (SRT) for recurrent glioma using CyberKnife.
Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. [2021]The safety and efficacy of dose-escalated radiotherapy with intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) remain unclear in salvage radiotherapy (SRT) after radical prostatectomy. We examined the impact of these advanced radiotherapy techniques and dose intensification on the toxicity of SRT. This multi-institutional retrospective study included 421 patients who underwent SRT at the median dose of 66 Gy in 2-Gy fractions. IMRT and IGRT were used for 225 (53%) and 321 (76%) patients, respectively. At the median follow-up of 50 months, the cumulative incidence of late grade 2 or higher gastrointestinal (GI) and genitourinary (GU) toxicities was 4.8% and 24%, respectively. Multivariate analysis revealed that the non-use of either IMRT or IGRT, or both (hazard ratio [HR] 3.1, 95% confidence interval [CI] 1.8-5.4, p
Repeated stereotactic radiosurgery for recurrent brain metastases: An effective strategy to control intracranial oligometastatic disease. [2020]Due to improvements in systemic therapies and longer survivals, cancer patients frequently present with recurrent brain metastases (BM). The optimal therapeutic strategies for limited brain relapse remain undefined. We analyzed tumor control and survival in patients treated with salvage focal radiotherapy in our center. Thirty-three patients with 112 BM received salvage stereotactic radiosurgery (SRS) or fractionated stereotactic radiotherapy (FSRT) for local or regional recurrences. Local progression was observed in 11 BM (9.8 %). After 1 year, 72 % of patients were free of distant brain failure, and the 2-year overall survival (OS) was 37.7 %. No increase in toxicity or neurologically related deaths were observed. The 2- and 3-year whole brain radiation therapy free survival (WFS) rates were 92.9 % and 77.4 %, respectively. Hence, focal radiotherapy is a feasible salvage of recurrent BM in selected group of patients with limited brain disease, achieving a maintained intracranial control and less neurological toxicity.
A Novel Salvage Option for Local Failure in Prostate Cancer, Reirradiation Using External Beam or Stereotactic Radiation Therapy: Systematic Review and Meta-Analysis. [2022]Reirradiation (re-RT) using external beam radiation therapy (EBRT) is a novel salvage strategy for local failure in prostate cancer. We performed a systematic review describing oncologic and toxicity outcomes for salvage EBRT/stereotactic radiation therapy (SBRT) re-RT.
Salvage Radiation Therapy for Patients With Relapsing Glioblastoma Multiforme and the Role of Slow Fractionation. [2022]Salvage radiation therapy (SRT) can be offered to patients with relapsing glioblastoma multiforme (GBM). Here we report our experience with a schedule extending the treatment time of SRT with the aim to prolong the cytotoxic effect of ionizing radiation while minimizing the cytotoxic hazards for the surrounding brain.
Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. [2023]This updated report on image guided radiation therapy (IGRT) is part of a series of consensus-based white papers previously published by the American Society for Radiation Oncology addressing patient safety. Since the first white papers were published, IGRT technology and procedures have progressed significantly such that these procedures are now more commonly used. The use of IGRT has now extended beyond high-precision treatments, such as stereotactic radiosurgery and stereotactic body radiation therapy, and into routine clinical practice for many treatment techniques and anatomic sites. Therefore, quality and patient safety considerations for these techniques remain an important area of focus.
The evolving role of reirradiation in the management of recurrent brain tumors. [2023]Despite aggressive management consisting of surgery, radiation therapy (RT), and systemic therapy given alone or in combination, a significant proportion of patients with brain tumors will experience tumor recurrence. For these patients, no standard of care exists and management of either primary or metastatic recurrent tumors remains challenging.Advances in imaging and RT technology have enabled more precise tumor localization and dose delivery, leading to a reduction in the volume of health brain tissue exposed to high radiation doses. Radiation techniques have evolved from three-dimensional (3-D) conformal RT to the development of sophisticated techniques, including intensity modulated radiation therapy (IMRT), volumetric arc therapy (VMAT), and stereotactic techniques, either stereotactic radiosurgery (SRS) or stereotactic radiotherapy (SRT). Several studies have suggested that a second course of RT is a feasible treatment option in patients with a recurrent tumor; however, survival benefit and treatment related toxicity of reirradiation, given alone or in combination with other focal or systemic therapies, remain a controversial issue.We provide a critical overview of the current clinical status and technical challenges of reirradiation in patients with both recurrent primary brain tumors, such as gliomas, ependymomas, medulloblastomas, and meningiomas, and brain metastases. Relevant clinical questions such as the appropriate radiation technique and patient selection, the optimal radiation dose and fractionation, tolerance of the brain to a second course of RT, and the risk of adverse radiation effects have been critically discussed.